Desloratadine / pseudoephedrine Pregnancy and Breastfeeding Warnings

Brand names: Clarinex-D 12 Hour, Clarinex-D 24 Hour

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

Desloratadine / pseudoephedrine Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: C

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.

Animal studies have not been conducted with the combination of both active ingredients. Desloratadine was not teratogenic at 210 and 230 times the AUC at the recommended human dose, however a study at 120 times the AUC at the recommended human dose showed increased pre-implantation loss and decreased implantations and fetuses. At 50 times the AUC at the recommended human dose showed reduced body weight and slow righting reflex in the pups, and at 7 times the AUC at the recommended human dose desloratadine had no effects on pup development. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Desloratadine / pseudoephedrine Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the risk to the child.

Excreted into human milk: Yes (both desloratadine and pseudoephedrine)

Comments:
-Pseudoephedrine may cause irritability in the nursing infant.
-A single pseudoephedrine dose decreases milk production, and combined with desloratadine may have a negative effect on lactation.

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